Sterling
This article was originally published in The Tan Sheet
Executive Summary
Receives July 28 warning letter from FDA citing the firm for employing faulty tamper-resistant packaging for 24-count bottles of Panadol Regular Strength, Lot PA23HN and 50-caplet bottles of Panadol Extra Strength, Lot PA061C. "For example," the letter explains, "your imprinted foil bottle mouth seals were easily removed and reapplied without visible evidence of entry since the cotton pledgets prevented the foil seals from adhering to the bottle mouths." Sterling said that it is reviewing the matter and expects to respond to FDA.